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OpenTrials
Completed

NCT Number: NCT06361277

To Evaluate the Pharmacokinetic Characteristics and Safety in Healthy Volunteers

The objective is to evaluate the safety and pharmacokinetic characteristics after co-administration of JW0202 and C2202 and co-administration of C2205 and JW0201 in healthy volunteers under fasting conditions

Completed

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Key information

Conditions

Healthy

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Trial Center, Jeonbuk National University Hospital

Jeonju, South Korea

About this study

Pharmacokinetic characteristics: Describes the blood concentration statistically by pharmacokinetic blood collection time and treatment group.

Safety: All adverse events are summarized in terms of the number of subjects, expression rate, and number of expressions of adverse reactions by treatment group.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy volunteers

Exclusion criteria

  • Subjects does not meet the Inclusion Criteria

Treatment and study plan

Reference Drug or Test Drug

Drug

Tablet, Oral, QD for 1 Day, Washout period is more than 7 days after administration

Other names: Reference Drug(C2205 and JW0201) or Test Drug(JW0202 and C2202)

Primary outcomes

  1. AUCt

    Time frame: Day1 0h ~ Day3 48h

    Describes the blood concentration statistically by pharmacokinetic blood collection time and treatment group.

  2. Cmax

    Time frame: Day1 0h ~ Day3 48h

    Describes the blood concentration statistically by pharmacokinetic blood collection time and treatment group.

Sponsors and collaborators

Lead sponsor

JW Pharmaceutical

Industry

Registry information

Official study title

A Randomized, Open-label, Single Dose, Crossover Study to Compare the Pharmacokinetic Characteristics and Safety of JW0202 and C2202 or C2205 and JW0201 After Oral Administration in Healthy Volunteers

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 11, 2024
Registry last updated
Apr 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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